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Literature review current through: Oct 2020. | This topic last updated: Apr 23, 2020.
INTRODUCTION
This topic will present a broad review of the role of cardiac pacing in a variety of
settings. The management of the specific disorders is discussed separately as is a
description of the different types of pacemakers and pacing modes. (See "Sinus node
dysfunction: Treatment" and "Third degree (complete) atrioventricular block" and
"Second degree atrioventricular block: Mobitz type II" and "Modes of cardiac pacing:
Nomenclature and selection".)
GENERAL CONSIDERATIONS
Disease in the His-Purkinje system is generally considered to be less stable and more
likely to progressively worsen. As a result, permanent pacemaker placement is more
likely to be recommended, as more likely to provide significant clinical benefit, in such
patients.
All cardiac pacemakers consist of two components: a pulse generator ( picture 1),
which provides the electrical impulse for myocardial stimulation; and one or more
electrodes (commonly referred to as leads), which deliver the electrical impulse from
the pulse generator to the myocardium. The original cardiac pacing systems consisted
of pulse generators in the abdomen with epicardial leads placed surgically. Over time,
pacemaker systems evolved to predominantly placing the pulse generator in a pre-
pectoral position with transvenously-placed endocardial leads, which were easier to
insert and required less extensive surgery. While transvenous leads may have superior
long-term function when compared with epicardial leads, there are other potential
long-term complications (eg, venous thrombosis, infection, lead malfunction, etc).
Leadless cardiac pacing systems, currently in development and in clinical trials, offer
the promise of long-term pacing capability without lead-associated complications.
● Infection
● Venous thrombosis and resultant subclavian vein occlusion
● Lead malfunction
● Tricuspid valve injury (resulting in tricuspid regurgitation)
● In the LEADLESS trial, which enrolled 33 patients with an indication for single-
chamber right ventricular (RV) pacing, the leadless device was successfully
implanted via transfemoral venous approach in 32 of 33 patients (97 percent) [3].
The primary endpoint, freedom from complications at 90 days, was achieved in 31
of 33 patients (94 percent). One patient suffered RV perforation and cardiac
tamponade during implantation and subsequently died. At three-year follow-up,
90 percent of the patients remained free of device-related adverse events [11].
● In the Micra Transcatheter Pacing Study, which enrolled 725 patients with an
indication for single-chamber RV pacing, the leadless device was successfully
placed in 719 patients (99.2 percent) [8]. The Kaplan-Meier estimate of freedom
from device-related adverse events at six months (one of the two primary
endpoints) was 96 percent. The second primary endpoint, <2 V mean pacing
capture threshold at 0.24 millisecond pulse width, was assessed at six months in a
subset of 297 patients, among whom 292 (98.3 percent) reached the primary
endpoint. Of the approximately 12 percent of patients with elevated pacing
thresholds at the time of device implantation (high >1.0 V and very high >1.5 V),
over 85 percent had returned to normal pacing thresholds (≤1.0 V) by six months
post-implant [13]. At intermediate-term follow-up (12 months for safety
outcomes), 96 percent of patients remained free of major device-related
complications, with a significantly lower risk of major complications compared
with historical control patients who received transvenous pacemakers (hazard
ratio 0.52; 95% CI 0.35-0.77) [14].
Leadless cardiac pacing systems have been approved for use in Europe since 2013,
and in April 2016, the first leadless cardiac pacing system was approved for use in the
United States [15]. As of December 2016, two leadless pacemaker systems are
commercially available, with slightly different sizes and implantation requirements
[16]:
● Nanostim (St. Jude Medical), which measures 4.2 x 0.6 cm and requires an 18-
French sheath
● Micra (Medtronic), which measures 2.6 x 0.7 cm and requires a 23-French
introducer sheath
In general, leadless pacemakers have been placed via the transfemoral approach, but
in select patients the leadless pacemaker has been successfully implanted via a
transjugular approach [17].
Following device approval and introduction into general clinical practice, patients have
been prospectively enrolled in a registry to allow for postmarketing "real world"
evaluation of safety and efficacy [3,4,6,18-26].
● Among a cohort of 1817 patients from the post-approval registry, 1801 (99.1
percent) had successful implantation of the Micra leadless pacemaker at 179
centers [18]. A total of 41 major complications were reported at 30-day follow-up
(2.3 percent), comparable to the major complication rate in the pre-approval
investigational trial.
● Among 16 patients from three leadless pacemaker trials [3,4,6] who subsequently
required device removal, the device was successfully extracted in 15 of 16 patients
(94 percent), including all five patients in whom the device was in place for <6
weeks [19]. In a subsequent report on the extraction experience among 1423
worldwide recipients of the Nanostim device, among whom 73 patients
underwent attempted device retrieval (implant duration ranging from one day to
four years), 66 devices (90 percent) were successfully retrieved [20]. Of the 73
attempted retrievals, 53 were done in response to the clinical alert about potential
battery malfunction, with the other 20 patients (1.4 percent) having another
clinical indication for device retrieval. This rate of necessary revision is similar to
the reported experience with the Micra device, in which an actuarial revision rate
of 1.4 percent has also been reported [21].
● A report has been published describing the successful removal of the Nanostim
device up to nearly three years post-implant [22].
● Among a small cohort of 43 patients who had the device implanted while on
anticoagulant therapy, only one patient experienced a bleeding complication [25].
While implantation appears safe in patients treated with warfarin or another oral
anticoagulant, additional data are required to guide the optimal approach to
implantation in this setting.
COMMON INDICATIONS
The most common indications for permanent pacemaker implantation are sinus node
dysfunction and high-grade or symptomatic atrioventricular (AV) block. Guidelines for
implantation of cardiac pacemakers have been published jointly by the American
College of Cardiology, the American Heart Association, and the Heart Rhythm Society
(ACC/AHA/HRS) [1]. Although there are occasional cases that cannot be categorized
according to these guidelines, they are, for the most part, all-encompassing and have
been widely endorsed. Similar and concordant guidelines have also been established
by the European Society of Cardiology [31].
Some indications for permanent pacing are relatively certain or unambiguous, while
others require considerable expertise and judgment. It is helpful to divide the
indications for pacemaker implantation into three specific categories, or classes, as
defined by the ACC/AHA/HRS guidelines [1]:
Sinus node dysfunction — The need for permanent pacing in patients with sinus
node dysfunction is based largely upon the correlation of bradycardia with symptoms (
table 1). While patients with a heart rate of less than 40 beats per minute or pauses
of greater than four seconds are more likely to develop symptoms, there is no
definitive threshold for heart rate (or pause length) that determines the absolute need
for a permanent pacemaker.
Class I — The following conditions are considered class I indications for pacemaker
placement [1,31]:
● Sinus bradycardia (heart rate <40 beats per minute) in a patient with symptoms
suggestive of bradycardia, but without a clearly demonstrated association
between bradycardia and symptoms.
● Chronic heart rates <40 beats per minute while awake in a minimally symptomatic
patient.
Patients with sinus bradycardia of lesser severity (heart rate >40 beats per minute)
who complain of dizziness or other symptoms that correlate with the slower rates are
also potential candidates for pacemaker therapy.
Sinus node dysfunction in some patients may be due to the effects of medications (eg,
antianginal or antiarrhythmic medications), a potentially reversible cause. However, if
the pertinent medications cannot be discontinued (ie, alternative therapies are
unavailable), permanent pacemaker insertion may be performed to allow for ongoing
therapy with the drugs causing sinus node dysfunction [1].
Class I — The following conditions represent severe conduction disease and are
generally considered to be class I indications for pacing:
Some controversy exists concerning asymptomatic patients with complete heart block
and a structurally normal heart (eg, congenital complete heart block). The
ACC/AHA/HRS guidelines classify patients with congenital complete heart block and
any high-risk feature (symptoms attributed to bradycardia, wide QRS rhythm, mean
daytime heart rate <50 beats per minute, complex ventricular ectopy, or ventricular
dysfunction) as having a class I indication for permanent pacemaker implantation,
with all others with congenital complete heart block as having a class IIa indication for
permanent pacemaker implantation [1]. In contrast, no distinction is made for third
degree block of any severity in the European guidelines [31]. Nevertheless, most
practitioners consider this condition a definite indication for pacemaker placement.
(See "Congenital third degree (complete) atrioventricular block", section on
'Treatment'.)
Class II — Patients with varying degrees of acquired AV block may still benefit from
pacemaker placement. In such patients, determinations are often based upon
correlation of bradycardia with symptoms, exclusion of other causes of symptoms, and
in rare instances based on results of electrophysiology (EP) testing.
AV block in some patients may be due to the effects of medications (eg, antianginal or
antiarrhythmic medications), a potentially reversible cause. However, if the pertinent
medications cannot be discontinued (ie, alternative therapies are unavailable),
permanent pacemaker insertion may be performed to allow for ongoing therapy with
the drugs causing AV block [1,32].
The use of pacemakers in this disorder is limited to selected patients whose syncopal
events are clearly associated with a cardioinhibitory or bradycardic event, or to those
with a probable bradycardic cause and no other explanation for syncope after a
thorough evaluation. Pacemaker treatment is usually effective in patients with an
isolated cardioinhibitory or bradycardic cause of syncope. However, since many
patients have both bradycardic and vasodepressor components, some patients with
an indication for pacemaker placement may not have a significant improvement in
symptoms with pacing. (See "Reflex syncope in adults and adolescents: Treatment".)
OTHER INDICATIONS
Due to this potential for rapid progression, patients with these disorders are
considered to have a class IIb indication for pacemaker placement even with first
degree AV block, regardless of symptoms [1,34]. Some of these patients may also
require an implantable cardioverter defibrillator (ICD) or cardiac resynchronization
therapy (CRT) [35]. (See "Primary prevention of sudden cardiac death in patients with
cardiomyopathy and heart failure with reduced LVEF".)
Long QT syndrome — High-risk patients with congenital long QT syndrome have been
treated with pacemakers to prevent ventricular arrhythmias, generally with a dual
chamber pacemaker. However, most of these patients are now treated with an
implantable cardioverter-defibrillator, which has pacing capability as well. (See
"Congenital long QT syndrome: Treatment".)
● Right bundle branch block with left axis deviation without syncope or other
symptoms compatible with intermittent AV block.
UpToDate offers two types of patient education materials, "The Basics" and "Beyond
the Basics." The Basics patient education pieces are written in plain language, at the
5th to 6th grade reading level, and they answer the four or five key questions a patient
might have about a given condition. These articles are best for patients who want a
general overview and who prefer short, easy-to-read materials. Beyond the Basics
patient education pieces are longer, more sophisticated, and more detailed. These
articles are written at the 10th to 12th grade reading level and are best for patients who
want in-depth information and are comfortable with some medical jargon.
Here are the patient education articles that are relevant to this topic. We encourage
you to print or e-mail these topics to your patients. (You can also locate patient
education articles on a variety of subjects by searching on "patient info" and the
keyword(s) of interest.)
● Basics topic (see "Patient education: Pacemakers (The Basics)" and "Patient
education: Bradycardia (The Basics)")
● Beyond the Basics topic (see "Patient education: Pacemakers (Beyond the Basics)")
● The most common indications for pacemaker implantation are sinus node
dysfunction followed by AV block. All other indications are much less common and
include neurocardiogenic syncope and iatrogenic causes (eg, post-AV node
ablation). While patients with a heart rate of less than 40 beats per minute, or
pauses of greater than four seconds, are more likely to develop symptoms, there
is no definitive threshold for heart rate (or pause length) which determines the
absolute need for a permanent pacemaker. (See 'Common indications' above.)
● With the advent of cardiac resynchronization therapy (CRT), it is important to also
take into consideration the patient's left ventricular function at the time a
pacemaker is considered. If the patient has left ventricular dysfunction and
requires frequent pacing, it may be appropriate to consider CRT or an implantable
cardioverter-defibrillator (ICD) for patients with heart failure symptoms and
reduced ejection fraction. (See "Cardiac resynchronization therapy in heart failure:
Indications".)
ACKNOWLEDGMENT
The UpToDate editorial staff would like to thank Dr. David L. Hayes for his past
contributions as an author to prior versions of this topic review.
REFERENCES
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Schematic representation of the normal intraventricular conduction system (His-Purkinje system). The
Bundle of His divides into the left bundle branch and right bundle branch. The left bundle branch
divides into anterior, posterior, and, in some cases, median fascicles.
AV: atrioventricular; RA: right atrium; LA: left atrium; RV: right ventricle; LV: left ventricle.
Pacemaker not
Pacemaker necessary Pacemaker probably necessary
necessary
Symptomatic bradycardia Symptomatic patients with sinus node dysfunction Asymptomatic sinus
with documented rates of <40 bpm without a node dysfunction
clear-cut association between significant
symptoms and the bradycardia
Pacemaker not
Pacemaker necessary Pacemaker probably necessary
necessary
Symptomatic patients with fascicular block Patients with syncope and bifascicular Asymptomatic fascicular
and significantly prolonged H-V interval by or trifascicular block with other block without AV block
electrophysiologic study etiologies of syncope excluded
Symptomatic patients with block distal to His Pacing-induced block distal to His at Asymptomatic fascicular
at atrial paced rates of less than 100-120 atrial paced rates of less than 130 bpm block and first degree AV
bpm block
Contributor Disclosures
Mark S Link, MD Patent Holder: Tufts Medical Center [Chest wall protector]. N A Mark Estes,
III, MD Consultant/Advisory Boards: Medtronic [Arrhythmias (Pacemakers and ICDs)]; St Jude
Medical [Arrhythmias (Pacemakers and ICDs)]; Abbott [Arrhythmias (Pacemakers and ICDs)];
Boston Scientific [Arrhythmias (Pacemakers and ICDs)]. Susan B Yeon, MD, JD, FACC Nothing to
disclose
Contributor disclosures are reviewed for conflicts of interest by the editorial group. When found,
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